Evidence map›Paper›PMID 33321139›Full record

ArticleJournal of pharmaceutical sciences2021

Addressing the Cold Reality of mRNA Vaccine Stability.

Daan J A Crommelin, Thomas J Anchordoquy, David B Volkin, Wim Jiskoot, Enrico Mastrobattista

Open access · hybridAbstract read
In one paragraph

Article in Journal of pharmaceutical sciences, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 267 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
267citing papers in PubMed, 1 pooled it
26.4field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

267 citing papers in PubMed, 1 synthesis or guideline pooled it, 496 citations in OpenAlex.

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  11. Post-loading ribonucleic acid into lipid nanoparticle carriers.bioRxiv : the preprint server for biology · 2026
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207 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 4 institutions in 2 countries.

Daan J A CrommelinDepartment of Pharmaceutics, Utrecht Institute for Pharmaceutical Sciences, (UIPS), Faculty of Science, Utrecht University, Utrecht, the Netherlands. Electronic address: D.J.A.Crommelin@uu.nl.
Thomas J AnchordoquySkaggs School of Pharmacy and Pharmaceutical Sciences, Anschutz Medical Campus, University of Colorado, Aurora, CO 80045, USA.
David B VolkinDepartment of Pharmaceutical Chemistry, Vaccine Analytics and Formulation Center, University of Kansas, Lawrence, KS 66047, USA.
Wim JiskootDivision of BioTherapeutics, Leiden Academic Centre for Drug Research, Leiden University, Leiden, the Netherlands.
Enrico MastrobattistaDepartment of Pharmaceutics, Utrecht Institute for Pharmaceutical Sciences, (UIPS), Faculty of Science, Utrecht University, Utrecht, the Netherlands. Electronic address: E.Mastrobattista@uu.nl.
Utrecht University · NLLeiden University · NLUniversity of Colorado Anschutz Medical Campus · USUniversity of Kansas · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

As mRNA vaccines became the frontrunners in late-stage clinical trials to fight the COVID-19 pandemic, challenges surrounding their formulation and stability became readily apparent. In this commentary, we first describe company proposals, based on available public information, for the (frozen) storage of mRNA vaccine drug products across the vaccine supply chain. We then review the literature on the pharmaceutical stability of mRNA vaccine candidates, including attempts to improve their stability, analytical techniques to monitor their stability, and regulatory guidelines covering product characterization and storage stability. We conclude that systematic approaches to identify the key physicochemical degradation mechanism(s) of formulated mRNA vaccine candidates are currently lacking. Rational design of optimally stabilized mRNA vaccine formulations during storage, transport, and administration at refrigerated or ambient temperatures should thus have top priority in the pharmaceutical development community. In addition to evidence of human immunogenicity against multiple viral pathogens, including compelling efficacy results against COVID-19, another key strength of the mRNA vaccine approach is that it is readily adaptable to rapidly address future outbreaks of new emerging infectious diseases. Consequently, we should not wait for the next pandemic to address and solve the challenges associated with the stability and storage of formulated mRNA vaccines.

Indexed as

Vaccine Potency2019-nCoV Vaccine mRNA-1273BNT162 VaccineCold TemperatureCOVID-19COVID-19 VaccinesDrug StabilityDrug StorageHumansmRNA VaccinesRNA, MessengerRNA StabilitySARS-CoV-2Vaccines, Synthetic2019-nCoV Vaccine mRNA-1273BNT162 VaccineCOVID-19 VaccinesmRNA VaccinesRNA, MessengerVaccines, SyntheticCold chainCOVID-19FormulationLipid nanoparticlesmRNAShelf lifeStabilityVaccine

Identifiers

PMID33321139
PMCPMC7834447
OpenAlexW3110973116

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.